FDA product code OGU: Pierced Ear/Entry Cleaning Tray

OGU is the FDA product code for pierced ear/entry cleaning tray. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under OGU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

Contents typically includes: Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Classification

Recalls for OGU devices

openFDA lists no recalls for product code OGU.

Frequently asked questions

What is FDA product code OGU?

OGU is the FDA product code for pierced ear/entry cleaning tray. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.

What device class is OGU?

Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.

Next steps

• Run an FDA pathway report with predicate devices for product code OGU
• Run a recall and safety report across every OGU manufacturer
• Watch product code OGU for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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